ARIELLA HEMORRHOID GEL- lidocaine, phenylephrine hcl ointment 
YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD

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Ariella Hemorrhoid Gel

Drug Facts Drug Facts

Active ingredients Purpose

Lidocaine 6% ………………………….………...….Protectant Phenylephrine HCL 0.25%…………………………………………….……………………..Vasoconstrictor

Uses

-helps relieve itching and discomfort associated with hemorrhoids - temporarily shrinks swelling and relieves burning and pain -soothes and protects irritated tissue

For external and/or intrarectal use only

Ask a doctor before use if you have

-heart disease -high blood pressure - thyroid disease - diabetes -difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

When using this product do not exceed the recommended daily dosage unless directed by a doctor

Stop and ask a doctor if - bleeding occurs -condition worsens or does not improve within 7 days -introduction of the applicator into the rectum causes additional pain -an allergic reaction occurs - symptom does not improve or if redness, irritation, swelling, pain or other symptoms develop or increase

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away. (1-800-222-1222)

Warnings

Directions

-when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before application.

-apply half the gel in the applicator to the external affected area (only applies if you have external symptoms)

-find a comfortable position and gently insert about ½ inch into the rectum.

-push the end of the applicator to apply the remaining gel inside the rectum (Both steps are necessary for both internal and external symptoms as external hemorrhoid often comes with internal hemorrhoid)

-dispose the applicator after use.

-avoid movement for 1-3 hours

-Children under 12 years of age: ask a doctor

Other information store at 15-25°C (59-77°F)

Inactive ingredients

Borneol, Carbomer Homopolymer, Chlorhexidine Acetate, Glycerin, Thymol

ARIELLA HEMORRHOID GEL 
lidocaine, phenylephrine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83364-007(NDC:84010-001)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BORNEOL (UNII: M89NIB437X)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y)  
THYMOL (UNII: 3J50XA376E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83364-007-011 in 1 BOX06/25/2024
16 in 1 APPLICATOR
13 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00506/25/2024
Labeler - YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD (725220463)

Revised: 6/2024
Document Id: 1bbf56f2-2f72-601b-e063-6294a90a6e99
Set id: 1bbf56f2-2f71-601b-e063-6294a90a6e99
Version: 1
Effective Time: 20240625
 
YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD